Nuvisan

QA Engineer

• Recommends and maintains a quality management system
• Implements quality actions tailored to the site's activities
• Ensures site readiness for inspections and audits
• Manages archiving strategies and the release of technical batches

Quality Assurance Manager – Fixed-Term Contract

Manager

• Lead projects in the field of pharmaceutical analytics
• Plan and monitor the execution of pharmaceutical projects
• Organize and coordinate the project team
• Ensure technically sound, on-time and cost-efficient project delivery
• International project-related customer contact, possibly with a regional focus
• Support customer and regulatory audits (GMP, FDA inspections)
• Prepare and approve cross-functional documents, such as SOPs, test specifications, plans and reports

Project Manager – Pharmaceutical Analytics

• Sous la responsabilité du Pharmacien Responsable, Responsable Assurance Qualité il/elle veille au respect des BPF sur le site de Nuvisan
• Revue des dossiers relatifs aux lots de substances médicamenteuses/médicaments pour les produits commerciaux
• Vérification de la pertinence des informations réglementaires requises en rapport avec l'autorisation de mise sur le marché
• Revue et interprétation des déviations en rapport avec la fabrication de produits de biotechnologie
• Mise en place d'un système de management de la qualité
• Contribue à la mise en œuvre et au suivi du système de gestion de la qualité
• Audits internes et rédaction de rapports d'audit

Technicien Assurance Qualité – Spécialisé en Biotechnologies

Human Resources

• Coordinate and execute labor law-related matters in close collaboration with the HR Business Partnership team and external legal counsel
• Draft and revise works agreements and company policies
• Ensure compliance with labor law, internal company regulations and data protection requirements
• Review contract documents, works council hearings and certificates for accuracy
• Prepare and present analyses and reports for local and global stakeholders
• Support audits and internal reviews, particularly in the context of annual financial statement processes
• Maintain and update employee master data in the HR management system
• Implement new HR software, including vendor pre-selection, contract negotiations and change management
• Manage and update company policies, Standard Operating Procedures (SOPs) and statutory requirements, and communicate these to all employees
• Support the implementation of optimized job descriptions
• Perform document handovers, e.g., contract updates and amendment agreements, and act as a contact person for any follow-up questions
• Respond to and process employee inquiries and create knowledge articles on HR-specific topics
• Participate in local and global HR projects to optimize existing processes and systems
• Contribute to the ongoing optimization, harmonization and standardization of our HR processes

Senior HR Operations Specialist

• Central liaison between the HR department and the various business areas at our locations in Neu-Ulm and Grafing
• Advising and supporting approximately 500 managers, project leads and employees on all HR-related matters
• Conducting personnel, feedback and disciplinary discussions and supporting managers in conducting these conversations
• Close cooperation with management, works councils and other employee representative bodies
• Supporting organizational changes and assisting with structural adjustments as part of change management
• Steering and implementing regular talent and performance management processes and supporting succession planning
• Identifying training needs and developing appropriate measures for employee development
• Advising managers on initiatives to increase employee engagement
• Independently taking on internal HR projects and actively participating in HR working groups
• Supporting the preparation of the personnel cost budget and strategic workforce planning

Senior HR Business Partner

• As part of the Quality Assurance department, provides support to all functions within the department.
• Reviews all documents related to pharmaceutical product activities.
• Participates in the management and monitoring of quality-related processes.
• Contributes to the update of quality assurance documentation.
• Conducts internal audits.
• Performs qualification audits and periodic quality audits of suppliers and subcontractors.

Quality Assurance Technician – M/F

• Recommande, met en œuvre et maintient un système de gestion de la qualité
• Assure la préparation du site en vue des inspections des autorités sanitaires
• Définit des normes pour le programme de formation qualité
• Procède à la libération des lots techniques et des lots de cosmétiques